Pacer wire management devices and methods

ABSTRACT

An epicardial pacer wire management device can include a spool defining a recessed region that encompasses the spool. The recessed region can receive a portion of a pacer wire. The device can further include a connector attached to the spool, and the connector can be electrically coupled with an exposed tip of the pacer wire. The device can further include an electrical port attached to the spool that can communicate with a pacing control unit. The device may include an electrical communication line electrically coupled between the connector and the electrical port.

CROSS-REFERENCE TO RELATED APPLICATIONS

This invention claims priority, under 35 U.S.C. § 120, to the U.S.Non-Provisional patent application Ser. No. 15/892,257 to Ian Nolan Hesset al. filed on Feb. 8, 2018, and therethrough, to the U.S. ProvisionalPatent Application No. 62/456,292 to Ian Nolan Hess et al. filed on Feb.8, 2017, both of which are incorporated by reference herein in theirentirety.

BACKGROUND OF THE INVENTION Field of the Invention

The present disclosure relates to epicardial pacer wires, and relatesmore particularly to devices and methods for managing epicardial pacerwires.

BRIEF DESCRIPTION OF THE DRAWINGS

The written disclosure herein describes illustrative embodiments thatare non-limiting and non-exhaustive. Reference is made to certain ofsuch illustrative embodiments that are depicted in the figures, inwhich:

FIG. 1 is a perspective view of an embodiment of a pacer wire managementdevice in use with a patient;

FIG. 2 is a perspective view of the pacer wire management device of FIG.1;

FIG. 3 is an exploded perspective view of the pacer wire managementdevice of FIG. 1;

FIG. 4 is a cross-sectional perspective view of the pacer wiremanagement device, the cross-section having been taken along the viewline 4-4 in FIG. 2;

FIG. 5A is a schematic wiring diagram of a pacer wire management device;

FIG. 5B is a schematic wiring diagram of another embodiment of a pacerwire management device;

FIGS. 6A-6H are perspective views of various stages of an illustrativemethod of using a pacer wire management device, with FIG. 6H furtherincluding a cross-sectional view such as that depicted in FIG. 4;

FIG. 7 is a perspective view of another embodiment of a pacer wiremanagement device;

FIGS. 8A and 8B are perspective views of another embodiment of a pacerwire management device;

FIG. 9 is a perspective view of another embodiment of a pacer wiremanagement device; and

FIG. 10 is a cross-sectional perspective view of another embodiment of apacer wire management device.

DETAILED DESCRIPTION OF THE INVENTION

Numerous devices have been proposed and implemented for deliveringelectric pulses to the heart. One commonly used device is the epicardialpacemaker. Epicardial pacer wires are pacemaker leads usually made ofTeflon™ insulated stainless steel and are inserted into the epicardialsurface of the heart during coronary artery bypass surgery. These wiresare sutured to the atrium and/or ventricle of the heart by the surgeonand then brought through the subcutaneous tissue of the chest wall. Askin wire or lead may also be used.

Typically, epicardial pacer wires extend outwardly through the chest ofthe patient (e.g., six to twelve inches) and end in a stiff, uninsulatedtip. This tip is used for insertion into ventricular and/or atrial portsof a temporary pacemaker. This pacemaker may be used, for example, inthe case of heart dysrhythmias. Through these epicardial pacer wires,the temporary pacemaker delivers an electrical charge that stimulates anelectrical response in the heart, causing a heartbeat. This temporarycardiac pacing has proven to be a significant lifesaving technique forpost-operative cardiac patients.

Pacer wires generally come in pairs and run from their insertion site ineither the ventricles or atria, and out through the skin. Some patientsonly have one set of wires-either ventricular or atrial. Other patientsmay have both sets of wires. The atrial wires are on the right side ofthe patient and the ventricular wires are on the left side of thepatient. As previously noted, the wires are used to pace a patient'sheart during emergencies that may arise after open-heart surgery duringthe period that the heart is recovering from the shock of cardiac bypassand the trauma of surgery.

Known devices and methods for managing pacer wires suffer from a varietyof drawbacks. Pacer wire management can include storage and/orprotection of the pacer wires during periods between use. Pacer wiremanagement also includes that manner in which the wires are used forpacing.

Devices and methods for storing pacer wires often involve items that aredesigned or intended for other uses and lack consistency in application.For example, pacer wires are wrapped around such disparate items astongue depressors, syringe barrels, glass or plastic lab tubes, orneedle caps. In other instances, a finger cot or a torn-off finger of alatex/nitrile glove is used to store the pacer wires. In still otherinstances, the pacer wires are wound and taped directly to the skin ofthe patient (e.g., taped to the abdomen) using Tegaderm™ or other formof tape.

Many of the disadvantages of such storage methods are evident from justone of the foregoing examples: the use of lab tubes (e.g., glass tubesor plastic microtainers). Storing pacer wires in lab tubes is one of themore common approaches. For the best possible outcome using this method,each individual wire should be stored in a separate tube, the tubeshould be devoid of any gel, and lids should not be placed on the tubeswhen the wires are stored therein. Separate tubes are used to reduce thechances of forming a closed circuit by contacting the pacer wire tips.Gel-containing tubes should be avoided because the leads could becomecoated in the gel. If this happens, the gel may form an insulatingbarrier on the leads that can prevent the leads from conducingelectricity from the pacer control unit (also referred to herein as a“pacer box,” “pacing unit,” or “pacing control unit”), or statedotherwise, can prevent the leads from functioning properly. This erroris one that is easily made and one that may not be immediately apparentto the practitioner. Lids should not be placed on the tubes as this cancreate stress points on the frail wires and can result in broken wires.Pacer wires are fragile, and once a wire breaks, the entire circuit iscompromised. Although it is possible to pace with only one good wire,the method for doing so is time-consuming, cumbersome, and painful tothe patient. In particular, a skin lead that is embedded into the skinof the patient is used. Moreover, if the patient is in a slow(bradycardia) rhythm, there may not be sufficient time for placement ofa skin lead, and thus CPR or transcutaneous pacing may be used instead.These alternative approaches have drawbacks such as extreme discomfortto the patient and the potential for further injury to the patient.

Despite the negative results for doing so, practitioners do not alwaysadhere to, or may not be aware of, the foregoing precautions when usinglab tubes. For example, it is not uncommon for practitioners to placemultiple leads in the same tube, to use lids with tubes into which apacer wire has been inserted, and/or to use gel-containing tubes tostore pacer wires.

Another significant risk associated with current storage mechanisms ismicroshock, which is the transmission of undesirable electricity throughthe wires and to the heart, which can potentially cause fatalarrhythmias. For example, minute electric charges can be delivered tothe heart through the epicardial wires; although such charges areusually not felt by the patient, they can cause lethal ectopy. Sourcesof minute electric charges can include static electricity or ungrounded,unchecked electrical equipment, such as a hospital bed frame. Typically,the pacer wires are stored together in the same glass tube or fingercot, or they are both taped together underneath a clear occlusivedressing. When the pacer wires are stored together in such manners, theconductive tips of the leads are often in contact, thus creating acircuit that drastically increases the chances of microshock.

Moreover, when both wires are removed from the storage device, one wireis typically coupled to the pacer box cable while the other is leftdangling and potentially contacting a variety of surfaces, thusincreasing the chances of errant electricity being applied to the heart.This is an example of another form of pacer wire management-namely, theuse of pacer wires during a pacing event—that suffers drawbacks underpresent approaches.

A further drawback of present methodologies includes the delays theyintroduce to using the pacer wires. For example, known storage methodsusually require unraveling and/or untangling of the wires prior to use.Moreover, the practitioner must ensure that the leads are coupled to theproper polarity interfaces of the pacer box cable, and further, that thepacer box cable is connected to the proper port of the pacer box (i.e.,the atrial or ventricle port). Not only can this process betime-consuming, it also presents the risk of set-up error. Wires fromthe atria and wires from the ventricles can be difficult to distinguishfrom each other with all of the dressings, cables, wires, and otherequipment present on a patient. The wires may be labeled, but theselabels sometimes fall off. This creates potential for the wires to beplaced incorrectly into the pacer during an emergency, when time is ofthe utmost importance.

Another potential for set-up error involves situations where a skin leadis used for pacing. In such circumstances, the pacer wire leads must beinserted into the pacer box cable correctly or the heart will not bepaced. The skin lead must be inserted into the positive (+) slot on thecable and the heart lead must be inserted into the negative (−) slot onthe cable. During an emergency, it is easy to make a mistake and/or havedifficulty properly inserting the leads into the proper channels of thepacer box cable (i.e., into the designated positive (+) or negative (−)channel of a connection adapter at a proximal end of the cable)—whichcan require significant dexterity and fine motor skills even under calmcircumstances—due to, for example, adrenaline, commotion, distractions,etc.

Embodiments disclosed herein ameliorate or remedy one or more of theforegoing drawbacks of known pacer wire management. For example, variousembodiments provide a standardized method for storing pacer wires,provide heightened protection against microshock, protect pacer wiresfrom excess bending during storage and/or eliminate stress points in thewires during storage, provide a simplified mechanism for electricallycoupling the pacer wires to a pacer box, and/or provide a system forclearly distinguishing the positive pacer wire from the negative pacerwire for ready transfer of the pacer wires from the management device tothe pacer box cable in instances where a traditional pacer box cable isused. One or more of these and/or other or further advantages ofembodiments discussed herein will be apparent from the presentdisclosure.

FIG. 1 is a perspective view of an embodiment of a pacer wire managementdevice 100 in use with a patient 50. The patient 50 is depicted as aninfant. Although the device 100 is advantageously used in thepost-operative context of pediatric congenital heart disease surgeries,it should be understood that the device 100 is advantageous in furthercontexts, including for use with adults.

The patient 50 has been provided with epicardial pacer wires 60, 62.Each pacer wire 60, 62 is attached to the heart of the patient 50 at adistal end thereof. The pacer wires 60, 62 extend through insertion/exitsites 80, 82 in the skin 70, and the proximal portions of the pacerwires 60, 62 are disposed at an exterior of the patient 50. The device100 can be configured to store a majority, or substantially all, ofthese proximal portions of the pacer wires 60, 62, including proximalends 64, 66 thereof.

As shown in the illustrated embodiment, the device 100 can be fixedlysecured or otherwise coupled to the skin 70 of the patient 50. Inparticular, in the illustrated arrangement, the device 100 is attachedto the skin 70 of the chest of the patient 50. The device 100 can alsobe coupled to the skin 70 at other locations, such as on the belly ofthe patient 50. In FIG. 1, the patient 50 includes only one set of pacerwires 60, 62, which in the illustrated arrangement, are atrial wires. Inother instances, a patient 50 may only have one set of wires that areventricular wires. In still other instances, a patient 50 may have a setof ventricular wires and a separate set of atrial wires. In some of suchinstances, two pacer wire management devices can be used. In stillfurther instances, a patient 50 may only have one transcutaneous wirefor one or more of the atrial or ventricular regions. A skin wire orlead can also be used, and can be stored on the device analogous topacer wires 60, 62.

FIGS. 2-4 depict various views of the device 100. The device 100 caninclude a spool 102 about which the pacer wires 60, 62 can be wound. Inthe illustrated embodiment, the device 100 further includes a cap 104that can secure the pacer wires 60, 62 to the spool 102. As furtherdiscussed below, in some embodiments, the cap 104 can be selectivelyattachable to and detachable from the spool 102. In some embodiments,the device 100 includes a connector 106 via which the device 100 can beselectively attached to or detached from a mounting pad 108.

In some embodiments, the spool 102 can be substantially disk-shaped. Incertain embodiments, the shape of the spool 102 can be defined inrelation to the perimeter of a channel or groove 110 that extends aroundthe spool 102. For example, as shown in the illustrated embodiment, thespool 102 can be described as being is substantially round and/orcircular. In other embodiments, the shape of the spool 102 (or the shapeof a channel or groove 110) can be substantially oval. Other shapes andconfigurations are also contemplated.

The spool 102 can define an indentation, channel, or groove 110 intowhich the pacer wires 60, 62 are received. In the illustratedembodiment, the groove 110 is formed as a recess that extends radiallyinward relative to an outer surface of the spool 102. The groove 110extends around a full perimeter (e.g., circumference, in the illustratedembodiment) of the spool 102. In the illustrated embodiment, the groove110 is positioned at a base end of the spool 102. A depth (i.e., radialdimension) and/or height (i.e., longitudinal dimension) of the groove110 can be sufficiently large to ensure that those portions of the pacerwires 60, 62 that are wrapped about the spool 102 are recessed from theouter surface of the spool 102. Such an arrangement may inhibitinadvertent snagging of the wrapped portion of the pacer wires 60, 62.

In certain embodiments, the spool 102 can further define one or moregrooves or channels 112 (also depicted as 112P, 112N) that extend fromthe groove 110. A connector 114 (also depicted as 114P, 114N) can alsobe positioned at an end of each channel 112 that is opposite from thegroove 110. In some embodiments, the connector 114 comprises anelectrical connector 114. In particular embodiments, an electricalconnector 114P, 114N can be positioned at an end of each channel 112P,112N, respectively, that is opposite from the groove 110. The electricalconnectors 114P, 114N may also be referred to as terminals 114P, 114N.In some embodiments, the connectors 114P, 114N are embedded in the spool102. Stated otherwise, a material of which the spool 102 is formed canencompass the connectors 114P, 114N. In some embodiments, the spool 102comprises an insulating or dielectric material, and thus the connectors114P, 114N can be shielded from an environment around the spool 102. Thechannel 112P and the connector 114P can be configured for coupling witha positive pacer wire 60, while the channel 112N and the connector 114Ncan be configured for coupling with a negative pacer wire 62. In someembodiments, the connectors 114P, 114N can be configured to protect theexposed tips of the pacer wires 60, 62, such as by inhibiting contactwith moisture. For example, in some embodiments, the connectors 114P,114N can be configured to operate in manners such as or similar togrease plugs. The connectors 114P, 114N can be configured to bothphysically and electrically couple with the exposed tips of the pacerwires 60, 62. In other embodiments, the connectors 114P, 114N are onlyconfigured to physically couple the exposed tips of the pacer wires 60,62.

In the illustrated embodiment, the connector 114P and the channel 112Pdefine a longitudinal axis ALONG that is disposed at an angle α relativeto a plane (not shown) that extends through a full perimeter of thegroove 110. Stated otherwise, longitudinal axis ALONG defined by theconnector 114P and the channel 112P is disposed at an angle α relativeto a plane (not shown) that is transverse to an axis of rotation aboutwhich the pacer wire 60 is wound around the spool 102. The angle αand/or a length or other configuration of the channel 112P can provide asmooth transition from the connector 114P to the groove 110. Statedotherwise, the channel 112P, including the angle α at which it and/orthe connector 114P are oriented relative to the groove 110, can avoidsharp bends, sharp transitions, or kinks that might otherwiseundesirably bend and/or weaken the pacer wire 60. The angle α can beacute. In various embodiments, the angle α is no greater than 30, 45, or60 degrees. In the illustrated embodiment, the channel 112P is flared ata base end thereof, which is opposite from the connector 114P, which canalso assist in providing a smooth transition to the groove 110 and avoidbending the pacer wire 60.

The connector 114N and/or the channel 112N can be configured the same asor similar to the connector 114P and/or the channel 112P. For example,one or more of the connector 114N and the channel 112N can define alongitudinal axis ALONG that is disposed at an angle α, in manners suchas just described. The angle α may either be the same as or differentthan the angle α for the connector 114P and/or the channel 112P.

In some embodiments, an acute angle α points in a desired wrappingdirection. For example, in the illustrated embodiment, it can bedesirable to wrap the pacer wire 60 in a direction that is clockwiserelative to the device 100 in the orientation depicted in FIGS. 2-4.This wrapping direction can be preferred, as it can avoid the formationof sharp bends in the pacer wire 60. Similarly, the pacer wire 60 wouldbe unwrapped in a counterclockwise direction. In FIG. 2, the angle αpoints in the clockwise direction. In some embodiments, one or moreindicia 116 are provided on the spool 102 to indicate the preferreddirection of wrapping. The indicia 116 may include an arrow and/or textspecifying the preferred wrapping direction.

In the illustrated embodiment, the connectors 114P, 114N and thechannels 112P, 112N are angularly spaced from each other byapproximately 90 degrees. Other angular spacing is also possible. Forexample, in various embodiments, the angular spacing is within a rangeof from about 60 degrees to about 120 degrees, or within a range of fromabout 45 degrees to about 315 degrees, from about 60 degrees to about300 degrees, from about 90 degrees to about 270 degrees, or from about120 degrees to about 240 degrees. In some instances, a relatively largeangular spacing can assist in distinguishing the positive terminal 114Pfrom the negative terminal 114N and avoiding practitioner confusion ateither the time of coupling or decoupling the pacer wires 60, 62 to orfrom the device 100. In some embodiments, one or more indicia 118P, 118Nare provided on the spool 102 to distinguish the positive terminal 114Pfrom the negative terminal 114N. The indicia 118P, 118N may include anappropriate symbol (e.g., “+”, “−”) and/or text specifying the polarityof the terminal 114P, 114N. One or more portions of the pacer wires 60,62 can also be marked or otherwise labeled to distinguish the pacer wire60 that is to be coupled to the positive terminal 114P and the pacerwire 62 that is to be coupled to the negative terminal 114N. Forexample, the proximal portion of the pacer wires 60, 62 can be coloreddifferently (e.g., red and black, etc.) to distinguish the pacer wires60, 62 from one another.

With continued reference to FIGS. 2-4, the spool 102 can include a pairof channels or notches 120, 122 at an upper surface thereof. Inparticular, the notches 120, 122 can be regions that are recesseddownwardly from the upper surface of the spool 102. The notches 120, 122can be positioned at diametrically opposite sides of the spool 102. Asfurther discussed below, the pacer wires 60, 62 can be positioned withinthe notches 120, 122. A depth and/or width of the groove in each notch120, 122 can be sufficiently large to ensure that those portions of thepacer wires 60, 62 that are received within the notches 120, 122 arerecessed from the upper surface of the spool 102. Such an arrangementmay inhibit inadvertent snagging of the pacer wires 60, 62 at the upperend of the spool 102. In further embodiments, one or more additionalpairs of diametrically opposed notches 120, 122 may be present at theupper end of the spool 102, which can provide a user with an additionaldegree of flexibility in determining how tightly to wind the pacer wires60, 62 and/or where to position the device 100 on the body of thepatient 50. The notches 120, 122 can increase in depth in a radiallyinward direction. Such a configuration can assist in avoiding pinchingor kinking of the pacer wires 60, 62 when the cap 104 is secured to thespool 102.

With reference to FIGS. 3 and 4, the spool 102 can also define a recessor a cavity 130 at interior ends of the notches 120, 122. For example, arecess or cavity 130 can be disposed at a central region of the spool102. The spool 102 can also define a connection interface 132.

In some embodiments, the cap 104 can define a protrusion 140 that issized to be received within the recess or cavity 130 of the spool 102.The cap 104 can also define a connection interface 142 that isconfigured to cooperate with the connection interface 132 to secure thecap 104 to the spool 102. When coupled, the cap 104 and the spool 102can cooperate to define an enclosure or chamber 145 (see FIG. 4) intowhich a portion of the pacer wires 60, 62 can be received (see FIGS.6D-6F). Coupling the cap 104 to the spool 102, such as in the mannerdepicted in FIGS. 6D-6F (and described further below), can retain thepacer wires 60, 62 in a wound state.

In some embodiments, an outer surface of an upper portion of the cap 104and or the protrusion 140 can define the connection interface 142. Acomplementary portion of the spool 102 can define the connectioninterface 132. In some embodiments, the connection formed by theinterfaces 132, 142 is sufficiently strong to keep the cap 104 and thespool 102 in a coupled state under typical forces that may beencountered by the pacer wires 60, 62, such as inadvertent brushingagainst clothing, etc. In some embodiments, the connection issufficiently weak to permit the cap 104 to disengage from the spool 102in situations of greater strain, such as significant snagging. Forexample, an excessive pull on the pacer wires 60, 62 can cause the cap104 to pop off of, or otherwise disengage from, the spool 102, and thewound portion of the pacer wires 60, 62 may unravel from around thespool 102, thus serving as a strain relief mechanism that may, forexample, inhibit inadvertent extraction of the pacer wires 60, 62 fromthe patient 50. In various embodiments, the connection interfaces 132,142 can provide a friction-fit, snap-fit, or other releasableengagement. In other or further embodiments, the connection interfaces132, 142 may define complementary threading, a detent mechanism, orother suitable engagement mechanism.

With reference again to FIG. 2, the cap 104 can include any suitableindicia 148 indicating the type of wires housed by the device 100. Forexample, the indicia 148 may include text, such as a letter “A” or “V,”to indicate that the device 100 is being used to store either atrial orventricular leads. In other or further embodiments, the cap 104 may becolored to so indicate. For example, a blue cap 104 may be used foratrial leads, whereas a white cap 104 may be used for ventricular leads.In yet other or further embodiments, the spool 102 may be colored (e.g.,blue or white) or otherwise marked to indicate the type of leads that itstores.

As further detailed below, various types of caps 104 can be used. Forexample, in some embodiments, a cap 104 can be coupled or tethered tothe spool 102 such that the cap 104 remains coupled to the spool 102when the connection interfaces 132, 142 are disengaged (as is shown inFIG. 7). In still further embodiments, a cover or cap 104 can beconfigured to be disposed over the spool 102, as is shown in FIGS. 8Aand 8B. Other types of caps 104 can also be used.

With reference to FIG. 4, the device 100 can include a connector 106 forcoupling the spool 102 to a mounting pad 108. In some embodiments, theconnector 106 can be fixedly secured to the spool 102. And in particularembodiments, the connector 106 is integral with the spool 102. Theconnector 106 can define a connection interface 150 for coupling to acomplimentary connector 162 of a mounting pad 108. In some embodiments,the connection interface 150 permits selective coupling and decoupling.For example, a standard snap-fit engagement may be used. The device 100thus may be connected to the skin of the patient 50 via a mounting pad108.

In some embodiments, the connector 106 can include or be formed as anelectrical connector to electrically communicate with a mounting pad 108via the connector 162. In particular embodiments, the connector 106 canbe configured to electrically and/or physically couple the device 100 tothe mounting pad 108.

The mounting pad 108 may be of any suitable variety. For example, insome embodiments, the mounting pad 108 includes a flexible substrate 160that can be secured to the skin of a patient via a suitable gel oradhesive. In certain embodiments, the mounting pad 108 comprises anelectrode pad. Various types of electrode pads can be used, includingthose presently marketed and those that may be developed in the future.In some embodiments, the mounting pad 108 comprises an EKG pad. In otherembodiments, an electrode pad may be incorporated into the device 100.For example, the connectors 106, 162 may instead be formed as a unitaryelectrical contact, and the substrate 160 and/or adhesive may bepositioned at the bottom end of the device 100.

As previously discussed, in some instances, the mounting pad 108comprises an electrode pad that can be used to deliver electricalsignals to the heart via one of the leads (i.e., the positive lead 60),such as where only one pacer wire 60, 62 is attached at the heart of thepatient 50. For example, a mounting pad 108 comprising an electrode padcan be used in the place of current skin leads, which are generallyimplanted in the skin 70 of the patient 50. The practitioner may thusplace a mounting pad 108 comprising an electrode pad at a suitableregion on the patient 50 in order to achieve this end. A mounting pad108 comprising an electrode pad can also be used as a backup for one ormore skin leads. In some of such instances, the mounting pad 108 can beactivated if the one or more skin leads fail. In still furtherembodiments, a mounting pad 108 comprising an electrode pad can be usedin addition to one or more skin leads.

With reference to FIGS. 4 and 5A, in some embodiments the device 100 caninclude a connection, electrical connection interface, or electricalport 170, such as a socket or jack. In other embodiments, no suchelectrical port 170 is used. The port 170 may also be referred to as aquick-connect port 170. For example, electrical connections achieved viathe port 170 can be significantly quicker than can be achieved under thestandard practice of inserting the tips (also referred to asterminations) of the pacer wires 60, 62 into the connection ports of anelectrical cable for a pacer control unit and also tightening the tipsinto the connection ports. The port 170 can be attached to the spool 102in any suitable manner. In the illustrated embodiment, the port 170 isembedded in the spool 102. The illustrated port 170 is a female socket.Other suitable port arrangements are also contemplated.

In the illustrated embodiment, the quick-connect port 170 includes threeelectrical contacts 172, 174, 176. As schematically illustrated in FIG.5A, the electrical contacts 172, 174, 176 can be electrically coupledwith the connectors 114P, 114N, 106, respectively, in any suitablemanner. For example, the spool 102 can include electrical communicationlines or electrical leads 173, 175, 177 routed through a body or otherportion thereof along any suitable path to establish electrical pathwaysfor electrical communication between the electrical contacts 172, 174,176 and the connectors 114P, 114N, 106, respectively.

With reference to FIGS. 4, 5A, and 6H, the quick-connect port 170 canpermit ready electrical coupling of a pacer control unit 200 to thepacer wires 60, 62. In some embodiments, a cable 202 is used as acommunication interface between the control unit 200 and the device 100.For example, the cable 202 can either be permanently attached to thecontrol unit 200 or can be coupled thereto via a connector 220 at oneend. Another end of the cable 202 can include a connector 204 that isconfigured to interface with the quick-connect port 170 of the device100. For example, in the illustrated embodiment, connector 204 comprisesa male jack connector 205 that is inserted into the port 170. Suchinsertion establishes contact between electrical contacts 212, 214, 216of the connector 205 and the electrical contacts 172, 174, 176 of theport 170. The control unit 200 thus can provide electrical signals toone or more of the connectors 114P, 114N, 106 via the electricalcontacts 212, 214, 216.

In certain embodiments, the cable 202 indirectly connects the device 100to the control unit 200. For example, the connector 220 can beconfigured to couple with a standard cable that requires insertion andclamping of exposed leads within a pair of connection ports, and thestandard cable is in turn coupled to the control unit 200.

A variety of different operational modes of the control unit 200 arecontemplated. For example, in some instances, the control unit 200 mayprovide signals to each of the electrical contacts 212, 214, 216. Inother instances, the control unit 200 may only provide signals to theelectrical contacts 212, 214. This operational mode corresponds withstandard control units 200 that provide signals to the two implantedpacer wires 60, 62. In some of such instances, the additional contact216 that is in electrical communication with the connector 106 liesdormant in this operational mode. For such a mode, a standard controlunit 200 that may not be capable of multi-mode operation may be used.

In some instances, the control unit 200 may only provide signals to thecontacts 214, 216. This operational mode corresponds with using animplanted lead 62 as the negative terminal and the connector 106 (andhence the electrode pad 108) as the positive terminal, such as areplacement for a typical skin lead. In some instances, the additionalcontact 212 that is in electrical communication with the connector 114Plies dormant in this operational mode.

In some instances, it is possible to switch between the two operationalmodes just described by using any suitable type of switch (e.g.,mechanical, electrical) at one or more positions along the communicationpathway. For example, the one or more switches may be incorporated intothe control unit 200, the cable 202, or the device 100. For example, theone or more switches may be used to selectively activate some or all ofthe communication pathway that includes the electrical contacts 212, 172and the connector 114P, while deactivating some or all of thecommunication pathway that includes the electrical contacts 216, 176 andthe connector 106, and vice versa.

In certain embodiments, the device 100 includes a polarity switch 179′,such shown in FIG. 5B. As shown in FIG. 5B, the switch 179′ (e.g.,mechanical, electrical) can be disposed along the communication pathway.The switch 179′ can also be configured to reverse the polarity of thedevice 100. For example, a switch 179′ can be used to selectively changeone or more electrical communication lines 173′, 175′ from a firstelectrical port terminal (e.g., 114P′) to a second electrical portterminal (e.g., 114N′). With reference to FIG. 5B, for instance, aswitch 149′ can be used to change the communication pathways that extendbetween electrical contacts 172′, 174′ and the connectors 114P′, 114N′.In a first position (e.g., a normal position) electrical contact 172′ iselectrically coupled to connector 114P′ via electrical communicationline 173′, and electrical contact 174′ is coupled to connector 114N′ viaelectrical communication line 175′. In a second position (e.g., areverse position) electrical contact 172′ is electrically coupled toconnector 114N′ via electrical communication line 175′, and electricalcontact 174′ is coupled to connector 114P′ via electrical communicationline 173′.

Incorporation of such a switch 179′ can be advantageous in many ways.For example, use of a switch 179′ can aid in instances in which thepacer wires 60, 62 are coupled with the device 100 incorrectly, orbackwards. For example, in some instances a pacer wire 62 extending tothe heart is connected to the positive terminal 114P′ rather than thenegative terminal 114N′. Use of a switch 179′ can also aid in instancesin which a pacer wire 60, 62 fails. For example, in some instances thepacer wire 62 connected to the negative terminal 114N′ may break orotherwise fail. In such instances, it may be advantageous to switch thecommunication pathway from electrical contact 174′ such that it extendsto a second pacer wire 60. Further, a separate skin wire can be used, orthe device 100 can be coupled to an electrical pad for skin terminationvia connector 106. For example, as shown in the illustrated embodiment,an electrical pathway in port 170′ can extend from electrical contact176′ to the connector 106 along the electrical communication line 177′.Other types of switches and arrangements of switches can also be used.

FIGS. 6A-6H depict illustrative stages of an illustrative method ofusing the device 100. FI. 6A depicts a stage in which a region 72 of theskin 70 of the patient is prepared for attachment of the mounting pad108 thereto (which can include an electrode or electrode pad). Anysuitable preparation method is contemplated, and may be conductedaccording to accepted protocols.

FIG. 6B depicts attachment of the mounting pad 108 to the region 72 ofprepared skin 70. In many instances, this stage involves any suitableattachment method, and may be conducted according to accepted protocols.

FIG. 6C depicts insertion of the terminal ends of the pacer wires 60, 62into the connectors 114P, 114N. Stated otherwise, the tips of the pacerwires 60, 62 are physically and electrically coupled to the connectors114P, 114N.

FIG. 6D depicts a stage in which the pacer wires 60, 62 have beenwrapped around the spool 102 several times while being pulled firmlyinto the groove 110. The wrapping may be achieved in any suitablemanner, such as by rotating the spool 102 relative to the patient. Suchan approach may, in some instances, introduce less twisting to the pacerwires 60, 62 than if the spool 102 is held rotationally at rest relativeto the patient and the pacer wires 60, 62 are wound around the spool102. In the depicted stage, the pacer wires 60, 62 have been woundaround the spool 102 in a clockwise direction. A portion of the pacerwires 60, 62 that is closer to insertion/exit sites 80, 82 (see FIG. 1)than is the wrapped portion of the pacer wires 60, 62 is laid in thenotches 122, 120 so as to span the cavity 130.

In some instances, one of the pacer wires 60, 62 may be longer than theother pacer wire 60, 62 at the stage depicted in FIG. 6C. In suchinstances, it may be desirable to begin the wrapping procedure bywrapping only the longer pacer wire 60, 62 into the groove 110 until theunwound portions of the pacer wires 60, 62 are substantially the samelength. From that point on, both pacer wires 60, 62 may be wrappedaround the spool 102 simultaneously.

FIG. 6E depicts a stage at which the cap 104 is being coupled with thespool 102. The protrusion 140 of the cap 104 will urge the portions ofthe pacer wires 60, 62 that span the cavity 130 downward into the cavity130.

FIG. 6F depicts a stage at which the device 100, with the pacer wires60, 62 secured thereto, is being coupled with the mounting pad 108. Inthe illustrated embodiment, the device 100 is forced downward onto themounting pad 108 to achieve a snap-fit engagement. Other types ofengagements can also be used.

FIG. 6G depicts a stage at which the device 100, with the pacer wires60, 62 secured thereto, has been coupled with the mounting pad 108. Inturn, the device 100 has been coupled to the patient 50. As can beappreciated, the distal ends or portions of the pacer wires 60, 62 canbe disposed within the patient (e.g., coupled to the heart) prior towrapping the pacer wires 60, 62 around the device 100.

FIG. 61H depicts a stage at which the device 100, now coupled with boththe pacer wires 60, 62 and the patient 50, has been electrically coupledwith the control unit 200. Operation of the control unit 200 and thedevice 100 in this coupled state has been discussed previously.

FIG. 7 is a perspective view of another embodiment of a pacer wiremanagement device 300 that resembles the device 100 in many respects.Accordingly, like features are designated with like reference numerals,with the leading digits incremented to “3.” Relevant disclosure setforth above regarding similarly identified features thus may not berepeated hereafter. Moreover, specific features of the device 300 maynot be shown or identified by a reference numeral in the drawings orspecifically discussed in the written description that follows. However,such features may clearly be the same, or substantially the same, asfeatures depicted in other embodiments and/or described with respect tosuch embodiments. Accordingly, the relevant descriptions of suchfeatures apply equally to the features of the device 300. Any suitablecombination of the features, and variations of the same, described withrespect to the device 100 can be employed with the device 300, and viceversa. This pattern of disclosure applies equally to further embodimentsdepicted in subsequent figures and described hereafter, wherein theleading digits may be further incremented.

As shown in FIG. 7, in some embodiments the device 300 includes a cap304 that is secured or otherwise tethered to the spool 302 using acoupling member 307. In certain embodiments, the coupling member 307comprises a tether. In other embodiments, the coupling member 307comprises a hinge or hinge-like structure. Other types of couplingmembers 307 can also be used.

As shown in the illustrated embodiment, the coupling member 307 can beconfigured to couple the cap 304 to the spool 302 such that the cap 304remains coupled to the spool 302 when the connection interfaces betweenthe cap 304 and spool 302 are disengaged. After the pacer wires 60, 62have been appropriately wrapped and/or positioned, the cap 304 can befurther coupled or engaged with the spool 302 in a position that atleast partially retains the pacer wires 60, 62 (such as the positiondepicted in FIG. 6H). For example, a protrusion on the cap 304 can beinserted into a recess or cavity of the spool 302 to aid in retainingthe pacer wires 60, 62.

FIGS. 8A and 8B depict perspective views of another embodiment of apacer wire management device 400. As shown in FIGS. 8A and 8B, thedevice 400 comprises a spool 402 and a cap 404 that are configured toretain one or more pacer wires 60, 62. In the illustrated embodiment,the cap 404 comprises a cover that can be disposed at least partiallyover the spool 402. The cap 404 further comprises a channel or port 409through which the pacer wires 60, 62 can extend. In some embodiments,the cap 404 is coupled or secured to the spool 402 using a couplingmember 407. In other embodiments, no coupling member 407 is used.

As disclosed herein, one or more pacer wires 60, 62 can be wrappedaround the spool 402. After the pacer wires 60, 62 have beenappropriately wrapped and/or positioned, the cap 402 can be coupled withand at least partially disposed over the spool 402. As shown in theillustrated embodiment of FIG. 8B, the cap 404 can cover or otherwiseenclose a portion of the spool 402. In particular embodiments, the cap404 covers the channel or groove into which the pacer wires 60, 62 arewound. For example, the cap 404 can cover at least a portion, or anentirety, of the channel or groove into which the pacer wires 60, 62 arewound. In such instances, the cap 404 can also at least partially, orcompletely, cover or enclose the portions of the pacer wires 60, 62 thatare wound around the spool 402 and disposed in the channel or groove.Such an arrangement can aid in keeping the pacer wires 60, 62 in awrapped position within the channel or groove. Stated otherwise, the cap404 can help prevent the pacer wires 60, 62 from unwinding orunspooling. Such an arrangement may also inhibit inadvertent snagging ofthe wrapped portion of the pacer wires 60, 62.

In certain embodiments, the cap 404 further comprises a protrusion 440,similar to the protrusion of the cap 104 discussed in relation to FIGS.1-4. When the cap 404 is coupled to the spool 402, the protrusion can bereceived within a recess or cavity 430 of the spool 402 to aid inretaining the pacer wires 60, 62. Additionally, it will be appreciatedthat the cap 404 and spool 402 can include various connectioninterfaces, such as the connection interfaces 132, 142 discussed inrelation to the cap 104 of FIGS. 1-4. Other types of connectioninterfaces can also be used to couple the cap 404 and spool 402 to oneanother, such as a connection interface disposed on the outer perimeterof the spool 402 and/or a connection interface disposed on an innerperimeter or inner surface of the cap 404.

FIG. 9 is a perspective view of yet another embodiment of a pacer wiremanagement device 500. As shown in FIG. 9, the shape of the device 500can vary as desired. For example, in the illustrated embodiment, thedevice 500 is elongated or substantially oval in shape. Stated anotherway, a perimeter that extends around the device 500 (or groove 510 ofthe device 500) is substantially oval in shape rather than circular (asis shown in the device of FIGS. 1-4).

The size of the device 500 can also vary as desired. For example, theperimeter around the device 500 can be made larger or smaller. Thethickness of the device 500 can also be increased (thicker) or decreased(thinner) as desired. It will thus be appreciated that the size and/orshape of the device 500 can be varied.

FIG. 10 is a cross-sectional perspective view of a pacer wire managementdevice 600 in accordance with another embodiment. In FIG. 10, a bottomsurface 655 of the spool 602 is curved or arcuate rather than flat. Suchan arrangement can aid in fitting the device 600 onto a portion ofpatient's body (e.g., such as fitting the device 600 onto a contour of apatient's belly). Such an arrangement can also aid in preventing thedevice 600 from rotating once it is coupled to a mounting pad 608 orotherwise disposed on a surface of the patient's skin. Other shapesand/or configurations can also be used.

Any methods disclosed herein comprise one or more steps or actions forperforming the described method. The method steps and/or actions may beinterchanged with one another. In other words, unless a specific orderof steps or actions is required for proper operation of the embodiment,the order and/or use of specific steps and/or actions may be modified.Moreover, sub routines or only a portion of a method illustrated in thedrawings, such as a small subset of a step, may be a separate method.Stated otherwise, some additional methods may include only a portion ofthe steps shown in a more detailed method.

References to approximations are made throughout this specification,such as by use of the terms “substantially,” “about” or “approximately.”For each such reference, it is to be understood that, in someembodiments, the value, feature, or characteristic may be specifiedwithout approximation. For example, where qualifiers such as“substantially,” “about” or “approximately” are used, these termsinclude within their scope the qualified words in the absence of theirqualifiers.

Reference throughout this specification to “an embodiment” or “theembodiment” means that a particular feature, structure or characteristicdescribed in connection with that embodiment is included in at least oneembodiment. Thus, the quoted phrases, or variations thereof, as recitedthroughout this specification are not necessarily all referring to thesame embodiment.

Similarly, it should be appreciated that in the above description ofembodiments, various features are sometimes grouped together in a singleembodiment, figure, or description thereof for the purpose ofstreamlining the disclosure. This method of disclosure, however, is notto be interpreted as reflecting an intention that any claim requiresmore features than those expressly recited in that claim. Rather, as thefollowing claims reflect, inventive aspects lie in a combination offewer than all features of any single foregoing disclosed embodiment.

The claims following this written disclosure are hereby expresslyincorporated into the present written disclosure, with each claimstanding on its own as a separate embodiment. This disclosure includesall permutations of the independent claims with their dependent claims.Moreover, additional embodiments capable of derivation from theindependent and dependent claims that follow are also expresslyincorporated into the present written description. These additionalembodiments are determined by replacing the dependency of a givendependent claim with the phrase “any of the preceding claims up to andincluding claim [x],” where the bracketed term “[x]” is replaced withthe number of the most recently recited independent claim. For example,for the first claim set that begins with independent claim 1, claim 3can depend from either of claims 1 and 2, with these separatedependencies yielding two distinct embodiments; claim 4 can depend fromany one of claim 1, 2, or 3, with these separate dependencies yieldingthree distinct embodiments; claim 5 can depend from any one of claim 1,2, 3, or 4, with these separate dependencies yielding four distinctembodiments; and so on.

Recitation in the claims of the term “first” with respect to a featureor element does not necessarily imply the existence of a second oradditional such feature or element. Elements specifically recited inmeans-plus-function format, if any, are intended to be construed inaccordance with 35 U.S.C. § 112(f). Embodiments of the invention inwhich an exclusive property or privilege is claimed are defined asfollows.

What is claimed is:
 1. A medical wire management device, comprising: a spool having: a front face; a back face opposite the front face; and a groove disposed between the front face and the back face and extending about a perimeter of the spool such that one or more wires may be wrapped there about; a first electrical connector attached to the spool near the groove, the first connector comprising an electrical connector that is configured to be electrically coupled with a wire; a second electrical connector attached to the spool spaced from the first electrical connector, not directly electrically coupled thereto, and configured to be electrically coupled with a wire; a physical connector disposed on the back face of the spool and configured to selectively physically couple the spool to a mounting pad; and an electrical port attached to the spool and including: a first electrical contact, and a second electrical contact electrically separate from the first electrical contact, wherein the first electrical contact is electrically coupled to the first electrical connector and the second electrical contact is electrically coupled to the second electrical connector.
 2. The device of claim 1, further comprising a recessed channel through the spool near the first electrical connector, the recessed channel being in communication with the groove.
 3. The device of claim 2, wherein the recessed channel defines an acute angle relative to the groove.
 4. The device of claim 1, further comprising a cap shaped to cover and enclose the spool, the cap being selectably coupleable over the spool.
 5. The device of claim 1, wherein the physical connector is also in electrical communication with the port.
 6. The device of claim 5, wherein the physical connector is in electrical communication with the first electrical connector but not in electrical communication with the second electrical connector.
 7. The device of claim 1, wherein the electrical port is a female socket extending into the spool through a side face of the spool that is adjacent to the front face of the spool.
 8. The device of claim 1, further comprising one or more indicia to specify the polarity of the first electrical connector.
 9. The device of claim 1, further comprising a polarity switch functionally coupled to the electrical port such that when switched the polarity switch swaps electrical connectivity of the first electrical contact and the second electrical contact with respect to each of the first electrical connector and the second electrical connector.
 10. A medical wire management kit, comprising: the medical wire management device of claim 1; and a mounting pad having a connector button protruding therefrom to which the physical connector selectably connects.
 11. The kit of claim 10, further comprising a cap configured to couple with the spool.
 12. The kit of claim 10, further comprising a cable having a connector jack that couples to the electrical port. 